Immuno-Oncology Summit looks at how to apply new science and technology in developing effective and safe immunotherapies

Cambridge Healthtech Institute’s 5th Annual Immuno-Oncology Summit makes a return trip to Boston this year after gracing the city last
year, bringing to the Boston Sheraton Hotel an extensive and diverse array of programming to help support researchers in developing the next generation of
immunotherapies.

As Cambridge Healthtech Institute (CHI) notes, immuno-oncology (IO) researchers are changing the way
cancer is treated “by unleashing the immune system and achieving functional cures in some cancers.”

CHI says that this year's IO Summit has been designed to give attendees a complete picture of the field and its advances with 12 conference
tracks, one in-depth training seminar and four instructional short courses, with topics including immunotherapy discovery, development, biomarkers and
translational oncology as well as emerging topic areas such as cancer vaccines, oncolytic viruses and advances in synthetic biology techniques.

“Overall, this event provides a focused look at how researchers are applying new science and technology in the
development of effective and safe immunotherapies,” according to CHI. The conference program’s educational sessions are broken down broadly in
the five areas of development, translational IO, therapy, biomarkers and vaccines. Let’s take a peek at a few of the offerings in each arena.

Development

One of the areas under the development umbrella
that the IO Summit will explore is immunomodulatory therapeutic antibodies for cancer, which have been driven, CHI notes, in large part by recent regulatory
approvals and a succession of favorable clinical data.

That said, this space is said to be rapidly filling with
agents directed against similar targets. Also, issues with non-responders and a limited amount of capacity for clinical studies have created barriers for
emerging companies wishing to enter this space, according to CHI, and thus it wanted to explore the science and strategies behind developing unique
approaches to the unmet medical needs in this market. Also in the mix are updates on mechanistic understandings of efficacy, side effects and patient
populations.

This program will kick off with a keynote presentation by Dr. Gregory Adams of Eleven Biotherapeutics
titled “Enabling Effective Immuno-Oncology,” looking at the promise of

checkpoint inhibitors and other
immune-oncology agents that have shown significant promise and discussing strategies that may be used to effectively set the stage for immune-oncology
treatments.

Combination cancer immunotherapy will also be a focus under the development theme, examining in part
how the clinical and regulatory successes of checkpoint proteins are driving a resurgence of interest in immunotherapy as a primary form of cancer treatment.
This topic area will also explore the scientific and strategic considerations for different immunotherapy combination strategies and consider the business
and clinical challenges facing research organizations wanting to successfully link their therapeutic programs to approved checkpoint inhibitors.

The keynote kicking off this part of the development programming is “Combination Cancer Immunotherapy: Current State
and Future Opportunities” by Dr. Jon Wigginton of MacroGenics, who will address guiding principles in the clinical development of immune-oncology
combinations, including patient selection, dose and schedule selection and optimizing risk/benefit, along with an analysis of the unique role and key
considerations for bispecific approaches for combination immunotherapy.

The third area under development covers
techniques in synthetic biology. This inaugural event was inspired by the fact that while cell-based immunotherapies provide an opportunity to incorporate
synthetic biology approaches to create safer, more effective cancer therapies, the field has not reached the point where genetic parts can be predictably
combined to achieve a desired outcome. Presenters will review the development of synthetic receptors, switches and circuits to control the location, duration
and strength of T cell activity against tumors; address cellular engineering and genome editing of host cells to improve the efficacy of cell-based cancer
therapeutics; and help attendees “build a solid foundation for a robust and impactful synthetic biology toolbox.”

Translational Immuno-Oncology

Preclinical and translational IO is one of the broad
areas under this educational track, and returns this year after a successful run at the IO Summit 2016 to help attendees learn about new clinically relevant
models for screening IO therapies and translational strategies to support clinical IO programs. As CHI notes, “The recent advancements in
immunotherapies, such as immune checkpoint modulators, bispecific antibodies and adoptive T cell transfer, are shifting the way cancer patients are treated.
Rapid development of novel immuno-oncology programs is creating the need for predictive preclinical models and translational strategies to understand
combination cancer therapy, study responses to cancer immunotherapy and identify novel biomarkers and targets.”

While that may be a returning area of interest, CHI also has an inaugural program this year under the translational track, looking at emerging
immuno-oncology targets, with CHI noting, “While cancer immunotherapy has made a giant leap in the past five years, the majority of therapies at
advanced stages of development are clustered in a similar target space. The increased investment in immuno-oncology has created an urgent opportunity to
discover and populate new target spaces that either present new classes of immunotherapies or can be used in combination with existing
products.”

As such, presenters will cover such topics as immunomodulatory inhibitor and agonist targets,
stromal and immune cell targets, as well as share case studies of preclinical and translational approaches to the discovery and validation of new immuno-
oncology targets and combinations.

Also under the translational IO banner is a day-and-a-half-long training
seminar titled “Immunology for Drug Discovery Scientists” that will cover the fundamentals of human immunology for biologists working in cancer
therapeutic areas at pharmaceutical and biotech organizations. The class will offer perspectives on how immune responses can be monitored by assessment of
biomarkers and modulated through biopharmaceutical intervention, as well as cover a historical perspective, basic mechanisms and approaches to developing
therapeutics and their combinations in immuno-oncology.

Therapy

This, the third of CHI’s broader tracks, is broken down into the areas of oncolytic virus immunotherapy, adoptive T cell therapy and
personalized cancer vaccines.

As CHI described the first of those three, “Oncolytic virotherapy represents
an exciting new area of cancer treatment which exploits a virus’ ability to selectively replicate and kill tumor tissue while stimulating a patient-
specific immune response against cancer. Interest in the field is at an all-time high following significant deals by Pfizer, Celgene, Amgen, BMS and
Boehringer Ingelheim; however, questions still remain around delivery, product and clinical development, preclinical modeling, scale-up, manufacturing and
suitable commercial models.”

The adoptive T cell track is a returning topic area—this being the fourth
time it has been offered—inspired by the accelerated pace of immunotherapy development, which, spurred by greater understanding of T cell biology and
promising patient outcomes, has led to immunotherapies accelerating at an unprecedented pace. The programming here will focus on the steps needed to deliver
CAR, TCR and TIL therapies to the patient by examining emerging science, autologous immune cell products and allogenic immune cell products.

Finally, the second annual Personalized Cancer Vaccines and Neoantigen Targeted Therapies meeting under the therapy umbrella
will gather thought leaders to share research and case studies for using patient-centric approaches that employ the immune system to beat cancer, including
utilizing next-generation sequencing to identify tumor-specific neoantigens, using in-silico tools to predict immunogenic neoepitopes and targeting
them with personalized vaccines or vaccine combination therapies.

Biomarkers

This track is split between quantitative immune profiling and biomarkers for immuno-oncology. The first area, broadly titled
“Quantitative Immune Profiling and Immune Monitoring,” is an inaugural event that will bring together presenters to cover quantitative approaches
to assess the state of the immune system, profile the tumor microenvironment and peripheral blood, determine tumor mutational burden and profile neoepitopes
and develop predictive and response biomarkers. Of the “Biomarkers for Immuno-Oncology” programming, now in its second year, CHI says, “As
pharmaceutical and biotechnology companies increase their investment in immuno-oncology programs to facilitate rapid development of novel immunotherapies,
there is increasing pressure to discover and validate relevant biomarkers.” As such, this meeting will bring together biomarkers experts from industry
and academia to address rapid development of predictive and prognostic IO biomarkers, utility of these biomarkers in clinical trials and their potential as
companion diagnostics.

Vaccines

Among the areas
covered in this track are advances in oncolytic virus immunotherapy, vaccine technologies, vaccine adjuvants and personalized cancer vaccines. The first and
fourth of those are the same programming as described earlier in the therapy track.

“Advances in Vaccine
Technologies” will present the latest advancements and applications of vaccine technology and a look forward to overcoming current challenges.
Synthetic vaccine candidates, genomic analysis of disease progression and vaccine response, structure-based antigen design and nanoparticle delivery systems
will be among the areas covered.

Of “Vaccine Adjuvants” CHI says, “Many recently developed
vaccines are comprised of recombinant molecules or subunits of pathogenic organisms, requiring formulation with adjuvants to increase and direct the immune
response. The benefit of adjuvants is clear: they may reduce the amount of antigen and number of vaccinations needed, accelerate the immune response,
increase cross-protection and improve efficacy in populations that are poor responders. As we continue to confront emerging and re-emerging disease threats
and progress toward developing new vaccines to improve global health, there is also an urgent need for the development of effective adjuvants.”

Plenary Keynotes

One of the major components of
the Immuno-Oncology Summit is the plenary keynote session, because, as CHI notes, it brings together hundreds of attendees from across all of the conference
programs, adding: “This session aims to cover pain points the entire field faces, with this year’s focus on FDA approval, market access and
reimbursement. Particular attention will be given to approval of adoptive cell therapies, which are on the cusp of breaking into the market, and cancer
vaccines. Then, an overview of the current healthcare system will be provided in the context of getting reimbursed for this new class of
therapeutics.”

The keynote addresses will take place on Tuesday, Aug. 29.

The first is “Regulatory and Scientific Considerations for Cancer Vaccines and Adoptive Cellular Immunotherapy” by Dr. Raj Puri,
division director of the Center for Biologics Evaluation and Research (CBER) at FDA. As he says of his presentation, “Cell and gene therapy, including
therapeutic vaccines and cellular immunotherapy products, are evaluated at FDA’s Center for Biologics Evaluation and Research in the Office of Tissues
and Advanced Therapies (OTAT), previously known as Office of Cellular, Tissue and Gene Therapies. I will discuss current general regulatory and scientific
considerations in the regulation of therapeutic cancer vaccines and cellular immunotherapy. In addition, research activities in OTAT will be
summarized.”

Puri is also chief of FDA’s Tumor Vaccines and Biotechnology Branch. Prior to joining
FDA/CBER, he was trained at National Cancer Institute’s Surgery Branch in cancer vaccines and immunotherapy approaches for cancer. At FDA, Puri
oversees evaluation, manufacturing and regulation of therapeutic vaccines, cellular immunotherapy, cellular and gene therapy, tissue engineering and
xenotransplantation products under various regulatory pathways. In addition, he oversees and manages FDA mission-relevant regulatory science-related research
programs to support cutting-edge medical product development, and he directs translational research program in his own lab in the field of cancer vaccines,
cancer targeting and cellular immunotherapy of cancer.

The second plenary keynote address is “Market Access
and Reimbursement for Immuno-Oncology Drugs in Today’s Healthcare System” by Dr. Gergana Zlateva, vice president, Payer Insights and Access,
Oncology at Pfizer. As described by CHI, “Now that immunotherapies have hit the market, with the promise of more to come, the healthcare system will
need to establish standards for cost and reimbursement of immuno-oncology agents. This talk will address how the healthcare marketplace can prepare for the
adoption of novel pricing and reimbursement models to increase patient access to immunotherapies. Establishing the value of IO therapies to payers and HTAs
will also be addressed in the context of pricing and evidence generation.”

At Pfizer, Zlateva’s team
provides both region-specific and global support in the development and implementation of market access, pricing, reimbursement and health technology
assessment strategies for Pfizer’s oncology portfolio. During her 13 year tenure with Pfizer, she has held various positions of increasing
responsibility covering health economics, outcomes research and pricing and reimbursement activities across several therapy areas and different geographies,
and she has led multiple cross-functional teams in preparation of pricing and reimbursement negotiations in developed markets. Prior to joining Pfizer in
2003, Zlateva worked for five years on public health, civil society and business development programs with several United Nations agencies.

The 2017 IO Summit Emerging Investigator Initiative

The
IO Summit 2017 will feature a new initiative wherein a select number of presentations will be given by rising stars from the field of immune-oncology. The
goal of this initiative is to not only showcase the future of the field, but also to provide our delegates with cutting-edge research that they won’t
see elsewhere.

Presentations include:

Immunomodulatory
Therapeutic Antibodies for Cancer

Immunomodulatory Antibodies—Potentiation by Fc Receptor Engagement

Dr. Rony Dahan of the Weizmann Institute of Science

The Role of Metabolism in Immune Response in Tumors: Merging the Past and
the Present of Tumor Microenvironment